In industrial nations, the incidence of melanoma has steadily risen over the previous 25 years, with the incidence in Australia being the highest in the world1. Although the perceived “melanoma epidemic” most probably represents increased detection of thin melanomas2, melanoma affects predominantly younger age groups resulting in a loss of productive-life years exceeded only by childhood malignancies and testicular cancer3,4. Melanoma is largely unresponsive to cytotoxic chemotherapy5, biological agents6,7 and various vaccination strategies8. A small subgroup of patients appear to benefit from biological and/or cytotoxic chemotherapies, but identifying these patients a priori is currently impossible, which necessitates the exposure of many patients to substantial toxicities with a low probability of benefit.
Once melanoma has metastasized to local lymph nodes, 70% of patients will die within 5 years9. The sub-group of patients with prolonged survival represents a unique cohort. No current adjuvant therapies offer an overall survival benefit, and while some clinicians offer interferon—α to improve disease-free survival10, many international centers offer no active adjuvant treatment outside clinical trials. Predicting which patients are likely to do well regardless of the use of adjuvant therapies would prevent needless toxicity, and enable the development of better therapeutic strategies targeting those more likely to obtain benefit. Better stratification of patients in adjuvant clinical trials will reduce both type I and type II errors. The 12 year update following the ECOG 1684 study and other randomized studies have demonstrated that interferon-α improves TTP but not overall survival in stage III melanoma5,10,11. Inherent heterogeneity within the patient populations, which are now well recognized but unable to be controlled for, may have confounded the promising effects on survival seen in the initial ECOG 1684 study10 and other smaller phase II studies. Stratifying those patients more likely to relapse may balance this heterogeneity and allow treatments to be compared more accurately.
There is a need for further tools to predict the prognosis of melanoma. This invention provides methods, compositions, kits, and devices based on prognostic cancer markers, specifically melanoma prognostic markers, to aid in the prognosis and treatment of cancer.